FDA.reportPublic FDA data

Tylenol Precise Cooling Pain Relieving Cream

Manufacturer
Kenvue Brands LLC
Effective date
2026-02-16
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:46:18

Label at a glance#

ProductTylenol Precise Cooling Pain Relieving
Active ingredientMENTHOL, UNSPECIFIED FORM, LIDOCAINE
Label structure11 sections

Indications and uses

For the temporary relief of pain

Dosage and administration

use only as directed adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily children under 12 years of age: ask a doctor

Storage and handling

store at 15 ◦ to 30 ◦ C (59 ◦ to 86 ◦ F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%............................................................................................... Topical analgesic

Menthol 1%.................................................................................................. Topical analgesic

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of pain

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - WHEN USING SECTION

▪ in large quantities, particularly over raw surfaces or blistered areas

When using this product

OTC - WHEN USING SECTION

▪ avoid contact with eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

▪ condition worsens or symptoms persist for more than 7 days

▪ symptoms clear up and occur again within a few days

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • use only as directed
  • adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 12 years of age: ask a doctor

Other Information

STORAGE AND HANDLING SECTION

store at 15 ◦ to 30 ◦ C (59 ◦ to 86 ◦ F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

carbomer copolymer, cetearyl olivate, cetyl alcohol, fragrance, glycerin, isopropyl palmitate, phenoxyethanol, sodium polyacrylate, sorbitan olivate, water

Questions?

OTC - QUESTIONS SECTION

Call 1-877-895-3665 (toll-free) or 215- 273-8755 (collect)

SPL UNCLASSIFIED SECTION

Distributed by:

Kenvue Brands LLC
Summit, NJ 07901

PRINCIPAL DISPLAY PANEL - 70g Tube in carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Cooling †

Pain Relieving

Cream

Lidocaine 4% Menthol 1%

TYLENOL ®

PRECISE ®

Fast acting †

Powerful

targeted

pain relief

Maximum Strength

Lidocaine without a

prescription

LIGHTLY SCENTED

FOR

EXTERNAL

USE ONLY

NET WT 2.5 OZ (70 g)

Tylenol_1Tylenol_1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
250912lidocaine 4 % / menthol 1 % Topical CreamPSN5
250912lidocaine 40 MG/ML / menthol 10 MG/ML Topical CreamSCD5
250912lidocaine 4 % / menthol 1 % Topical CreamSY5

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130074300353395GTIN-13: 0074300353395
EAN-13: 0074300353395
GTIN-12: 074300353395
UPC-A: 074300353395
GTIN storage (14 digits): 00074300353395		Tylenol_1.jpg
QR code linkQR Code2d.kenvue.com/01/00074300353395Tylenol_1.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69968-0793-1Tylenol Precise Cooling Pain Relieving14.2 g in 1 TUBECREAM14.25
69968-0793-1Tylenol Precise Cooling Pain Relieving1 in 1 CARTONCREAM15
69968-0793-2Tylenol Precise Cooling Pain Relieving1 in 1 CARTONCREAM15
69968-0793-2Tylenol Precise Cooling Pain Relieving70 g in 1 TUBECREAM705
69968-0793-4Tylenol Precise Cooling Pain Relieving113 g in 1 TUBECREAM1135
69968-0793-4Tylenol Precise Cooling Pain Relieving1 in 1 CARTONCREAM15
69968-0793-9Tylenol Precise Cooling Pain Relieving113 g in 1 TUBECREAM1135
69968-0793-9Tylenol Precise Cooling Pain Relieving2 in 1 CARTONCREAM25

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69968-079369968-0793-1, 69968-0793-4, 69968-0793-9, 69968-0793-2

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
CETEARYL OLIVATE58B69Q84JOIACT
CETYL ALCOHOL936JST6JCNIACT
GLYCERINPDC6A3C0OXIACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
PHENOXYETHANOLHIE492ZZ3TIACT
WATER059QF0KO0RIACT
LIDOCAINE98PI200987ACTIB
SODIUM POLYACRYLATE (2500000 MW)05I15JNI2JIACT
SORBITAN OLIVATEMDL271E3GRIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tylenol Precise Cooling Pain RelievingLIDOCAINE, MENTHOLKenvue Brands LLCfc0a3404-b174-3952-e053-6294a90a1e022026-02-16WarningsExact identifier
ndc (package): 69968-0793-1
ndc (package): 69968-0793-9
ndc (package): 69968-0793-4
ndc (package): 69968-0793-2
ndc (product): 69968-0793
ndc11 (package): 69968079302
ndc11 (package): 69968079304
ndc11 (package): 69968079309
ndc11 (package): 69968079301
spl id: 4aeeae88-3c06-e83e-e063-6294a90aab70
spl set id: fc0a3404-b174-3952-e053-6294a90a1e02
TYLENOL Extra Strength / TYLENOL Precise Cooling Pain ReliefACETAMINOPHEN, LIDOCAINE, MENTHOLKenvue Brands LLC2611e984-0dd5-bda1-e063-6394a90a559a2024-11-26WarningsExact identifier
ndc (package): 69968-0793-1
ndc11 (package): 69968079301

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.